PERCUFIX CATHETER CUFF

PERCUFIX CATHETER CUFF is an FDA 510(k)-cleared medical device (K842890) manufactured by Medi-Tech, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 3, 1984. Regulation: 8.